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Cancer Screening Test

Arm 1 - cancer group for Cancer (CORE-HH Trial)

N/A
Recruiting
Research Sponsored by Harbinger Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of cancer or non-cancer using Harbinger Test
Identify the correct tumor type by Harbinger Test
Performance for specific cancer types using Harbinger Test
Secondary outcome measures
Evaluate performance of the Harbinger Health Test by tumor stage
Evaluate performance of the Harbinger Health Test to discriminate hyperplasia Advanced Adenoma.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - non cancer groupExperimental Treatment1 Intervention
Arm 2 - non-cancer subjects (Not currently enrolling in this arm)
Group II: Arm 1 - cancer groupExperimental Treatment1 Intervention
Arm 1 - newly diagnosed cancer subjects

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Who is running the clinical trial?

Harbinger HealthLead Sponsor
May Orfali, MDStudy DirectorHarbinger Health
Hutan Ashrafian, MD MBA PhDStudy DirectorHarbinger Health
~3415 spots leftby Dec 2025
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